["...persistent depressive mood...].

Depressed patients are often asked to take part in clinical research studies that carry risk. These patients are generally assumed to be mentally competent to consent to research, since depression often leaves a patient's cognitive abilities intact. In this article, it is argued that many severely depressed patients may not be competent to consent because they cannot be considered accountable for their decisions. The article presents 2 arguments: first, that it is unclear whether the decisions of some severely depressed patients are authentically theirs, and second, that some severely depressed patients may not have the appropriate minimal degree of concern for their own well-being. It is argued that assessments of competence must take account of emotional factors, and that, if severely depressed patients are incompetent to consent, research studies involving a poor risk-benefit ratio will be much more difficult to justify.

Depressive Disorder↗

PubMed1997

Protecting subjects and fostering research. Striking the proper balance.

Bonnie reminds us of the heritage and limitations of human subjects research. He points out that over the years, the protection of human subjects in research has enjoyed progress, experienced false starts, and endured inflated expectations. Both he and Elliott call attention to the fact that IRB review rarely probes how researchers propose to deal with impairments to subjects' decision-making capacities. We agree to IRBs should be encouraged to rethink their roles. But, as Bonnie argues, this requires a systematic review of the roles and functions of IRB rather than ad hoc adjustments by individual institutional IRBs. His proposal that IRBs should be encouraged to be more vigilant and through in their monitoring of research is sound, especially if the subjects are vulnerable or the research is risky. A strength of Bonnie's review is that it suggests both specific ways to test competency and a range of options for IRBs to ensure that vulnerable subjects are protected from overzealous or overreaching researchers. His historical review and normative proposals are objective, balanced, and thoughtful. Elliott's critique seems to single out psychiatric research with depressed patients as a special problem area. Although his title emphasizes severely depressed patients, he sometimes appears to neglect the fact that depression ranges across a spectrum from mild to severe. Elliott's point is well taken that severely depressed patients who are clearly incompetent should not, unless proper safeguards are provided, be enrolled in research. But his analysis falters because his position does not in the end respect personal autonomy.

Depressive Disorder↗